Cleared Traditional

K782077 - LANCER ICE CUBE (FDA 510(k) Clearance)

Class I Pathology device.

K782077 · Sherwood Medical Industries · Pathology device
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Apr 1979
Decision
111d
Days
Class 1
Risk

K782077 is an FDA 510(k) clearance for the LANCER ICE CUBE. Classified as Freezer (product code JRM), Class I - General Controls.

Submitted by Sherwood Medical Industries (Mchenry, US). The FDA issued a Cleared decision on April 3, 1979 after a review of 111 days - within the typical 510(k) review window.

This device falls under the Pathology FDA review panel, regulated under 21 CFR 862.2050 - the FDA pathology device framework. The Traditional 510(k) pathway establishes clearance through substantial equivalence to a legally marketed predicate device, without requiring clinical trial data.

Device pattern: Standard predicate-based submission. Standard predicate reliance. This clearance follows a standard predicate-based equivalence path within the Pathology review framework, consistent with the majority of Class II 510(k) submissions.

View all Sherwood Medical Industries devices

Submission Details

510(k) Number K782077 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received December 13, 1978
Decision Date April 03, 1979
Days to Decision 111 days
Submission Type Traditional
Review Panel Pathology (PA)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
34d slower than avg
Panel avg: 77d · This submission: 111d
Pathway characteristics
Predicate-based equivalence.

Device Classification

Product Code JRM Freezer
Device Class Class 1 - General Controls
CFR Regulation 21 CFR 862.2050
What this classification means

Class I devices are subject to general controls only and most are exempt from 510(k) premarket notification. They represent the lowest regulatory burden in the FDA device framework.